FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
L-12, L-21, AND L-22 ELECTRODES
K Number: K780569
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
15
Review Days
64
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Basic Information
- Device Name
- L-12, L-21, AND L-22 ELECTRODES
- K Number
- K780569
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Coratomic, Inc.
- Date Received
- April 11, 1978
- Decision Date
- June 14, 1978
- Product Code
- DTB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTB), ordered by most recent decision date.
BIOTRONIK ENDOCARDIAL PACING LEADS
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PERMANENT PACING LEAD, MODEL PY2
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PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
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MODEL 5071 MYOCARDIAL PACING LEAD
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
FDA 510(k)
FDA Class 3
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Coratomic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS | Oct 8, 1986 | Substantially Equivalent |
| K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | Dec 15, 1982 | Substantially Equivalent |
| K820939 | C-101-P | Jun 22, 1982 | Substantially Equivalent |
| K821014 | CORATOMIC MODEL OVALITH 920BP | May 28, 1982 | Substantially Equivalent |
| K821033 | CORATOMIC MODEL OVALITH-920 | May 28, 1982 | Substantially Equivalent |
| K810808 | CORATOMIC MODEL OVALITH-920 | May 15, 1981 | Substantially Equivalent |
| K802689 | L-15T ENDOCARDIAL PACING ELECTRODE | Oct 28, 1980 | Unknown |
| K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | Feb 11, 1980 | Substantially Equivalent |
| K790446 | OVALITH-300 | Jul 30, 1979 | Substantially Equivalent |
| K781377 | OVALITH 10BP | Dec 4, 1978 | Substantially Equivalent |